A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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KHK6640

Group Type EXPERIMENTAL

KHK6640

Intervention Type DRUG

Single ascending dose and multiple ascending doses administration

Placebo

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Single ascending dose and multiple ascending doses administration

Interventions

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KHK6640

Single ascending dose and multiple ascending doses administration

Intervention Type DRUG

Matching Placebo

Single ascending dose and multiple ascending doses administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with prodromal AD or mild to moderate AD
* Clinical Dementia Rating (CDR) score of 0.5, 1.0, or 2.0
* Have a cognitive impairment
* Low Aβ and high Tau in Cerebrospinal fluid (CSF)
* Mini Mental State Examination (MMSE) score \> 16 at Screening

Exclusion Criteria

* Previous active treatment with an AD immunotherapy in an investigational study
* Use of another investigational drug within 30 days of screening
* History or presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
* Presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD
* Evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No